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Clinical Evaluation of a Cochlear Implant Sound Processor

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Contents

clinicaltrials.gov/study/NCT04237207
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT042372070
Health Conditions in Trial
Hearing loss
Hearing loss
0
Trial Recruitment Size
220
Trial Sponsor
Advanced Bionics
Advanced Bionics
0
Clinical Trial Start Date
December 17, 2019
0
Primary Completion Date
October 15, 2020
0
Study Completion Date
October 15, 2020
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Device0
Intervention Name
Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software0
301-M062 sound processor & software0
Interventional Trial Phase
Not Applicable0
Participating Facility
‌
Vanderbilt University Medical Center
0
Washington University Medical Center
Washington University Medical Center
0
Official Name
Evaluation of AutoSense OS on a Cochlear Implant Sound Processor Programmed With Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System0
Last Updated
May 13, 2022
0
Allocation Type
Non-Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0
Study summary

This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit

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